Κυριακή 10 Νοεμβρίου 2019

Responder Threshold for Patient-Oriented Eczema Measure (POEM) and Children’s Dermatology Life Quality Index (CDLQI) in Adolescents with Atopic Dermatitis

Abstract

Introduction

The Patient-Oriented Eczema Measure (POEM) assesses patient-reported frequency of atopic dermatitis (AD) symptoms, while the Children’s Dermatology Life Quality Index (CDLQI) measures the impact of skin disease on health-related quality of life (HRQoL) in children. There is currently no threshold for clinically meaningful within-person change in POEM or CDLQI scores in adolescents. Here we empirically derive within-person thresholds of meaningful within-person change in POEM and CDLQI scores in adolescents with moderate-to-severe AD.

Methods

Data were used from a phase 3, randomized, double-blind, placebo-controlled trial of dupilumab in adolescents (aged ≥ 12 to < 18 years) with moderate-to-severe AD. Anchor-based methods were employed using the mean change in POEM and CDLQI scores from baseline to week 16 linked with a 1-point improvement in Patient Global Assessment of Disease (PGAD), a score of “a little better” on the Patient Global Assessment of Treatment effect (PGAT), a 50–74% improvement from baseline in the Eczema Area and Severity Index (EASI-50–74), and a 1-point improvement in Investigator’s Global Assessment (IGA) score.

Results

A mean change of − 7.8 and − 5.6 in the POEM score was associated with PGAD and PGAT anchors, respectively. EASI-50–74 was associated with a mean change in POEM score of − 8.2, while the IGA anchor was associated with a mean change of − 7.9 in POEM score. The mean changes in CDLQI score associated with PGAD and PGAT anchors were − 6.4 and − 6.6, respectively, while CDLQI mean scores changed by − 8.3 and − 8.0 for the EASI and IGA anchors, respectively.

Conclusion

In adolescents (aged ≥ 12 to < 18 years) with moderate-to-severe AD, a within-person change of 6–8 points in POEM and CDLQI scores, independently, can be considered a reasonable responder threshold for clinically meaningful change in each of the two scales, respectively.

Trial Registration

ClinicalTrials.gov Identifier: NCT03054428.

Funding

Sanofi and Regeneron Pharmaceuticals, Inc.

The Neuromodulatory Effect of Antipruritic Treatment of Chronic Prurigo

Abstract

Chronic prurigo is an extremely severe pruritic skin disease which presents with multiple, hyperkeratotic and erosive papules, nodules and/or plaques. Patients with this high-burden disease require effective therapies, but effective treatments with regulatory agency approval are currently lacking. Deeper understanding of the pathophysiology suggests that hypersensitive nerves play an important role in the development of chronic prurigo. Accordingly, a treatment with neuroactive substances which modulate hypersensitivity seems promising. Here, we review antipruritic therapies with a neuromodulative effect. Current treatment options, such as topical capsaicin or opioid-receptor modulators, and also novel and future treatment regimens, such as, for example, interleukin-31 antibodies and neurokinin-1 receptor antagonists, are discussed.

Revisiting Imiquimod for Treatment of Folliculotropic Mycosis Fungoides: A Case Report and Review of the Literature

Abstract

Folliculotropic mycosis fungoides (FMF) is an aggressive variant of mycosis fungoides (MF) characterized by infiltration of the hair follicle epithelium by neoplastic T cells. FMF demonstrates poor response rates to standard skin-directed therapies such as phototherapy and topical corticosteroids. Imiquimod, an immunomodulatory agent that stimulates the antitumor immune response, has been used successfully in treatment of early-stage MF. We report a 21-year-old patient with unilesional FMF who achieved clinical remission with imiquimod application. This case highlights a potential for use of imiquimod as a treatment option for patients with FMF and limited skin involvement.

Delusions of Parasitosis: An Update

Abstract

Delusional parasitosis, also known as delusional infestation or Ekbom syndrome, is a relatively infrequent psychotic disorder characterized by an unwavering false belief that there is a parasitic infestation of the skin, despite the absence of any medical evidence that could support this claim. Delusional parasitosis can be categorized into primary, secondary, and organic forms. Sometimes, close relatives also experience identical delusions. This phenomenon was reported to occur in 5–15% of cases, and is known as shared psychotic disorder–delusional parasitosis with folie à deux. Patients with delusional parasitosis frequently seek help from many physicians. Close multidisciplinary cooperation between clinicians is often key to shortening the time taken to diagnose this disorder. Initiation of psychopharmacological therapy is a challenge, as many patients refuse any psychiatric treatment because of the stigma associated with mental illness and because of their firm belief that they have a parasitic infestation, not a psychiatric condition. For many patients, a sense of a lack of understanding leads to isolation and the development of depression symptoms, which is why it is crucial to earn the trust of such patients while taking care of them.

Scoping Review on the Use of Drugs Targeting JAK/STAT Pathway in Atopic Dermatitis, Vitiligo, and Alopecia Areata

Abstract

Introduction

The JAK/STAT signaling pathway is involved in the immune-mediated inflammatory skin diseases atopic dermatitis (AD), vitiligo, and alopecia areata (AA), and represents a potential target when developing treatments. So far, no drugs targeting this pathway have been approved for the treatment of dermatological diseases. We reviewed the use of drugs blocking the JAK/STAT pathway in the aforementioned diseases.

Methods

An a priori protocol was published. We used Joanna Briggs Institute Reviewer’s Manual methodology to conduct the review and PRISMA Extension for Scoping Review (PRISMA-ScR) to report results. MEDLINE, EMBASE, CINAHL, Scopus, and Web of Science databases were searched in a three-step approach on April 2019 by two researchers.

Results

Ninety-six mainly multicenter observational studies were included (66, 10, and 20 studies on AA, vitiligo, and AD, respectively). Tofacitinib and ruxolitinib were mainly used for the three diseases, and also upadacitinib, abrocitinib, baricitinib, cerdulatinib, delgocitinib, gusacitinib for AD, and baricitinib, PF-06700841, and PF-06651600 for AA. All patients with AD improved, whereas patients with vitiligo and patients with AA showed varied responses, including unresponsive cases. The safety profiles were similar for all drugs and diseases, mainly comprising mild or no adverse events.

Conclusions

Evidence on the efficacy and safety of drugs targeting the JAK/STAT pathway for the treatment of patients with AD, vitiligo, or AA is increasing but is still of low quality.

An Open-Label, Intra-Individual Study to Evaluate a Regimen of Three Cosmetic Products Combined with Medical Treatment of Rosacea: Cutaneous Tolerability and Effect on Hydration

Abstract

Introduction

Although rosacea management includes general skincare, previous studies have not evaluated comprehensive skincare regimens as adjuvants to other treatments.

Methods

The primary objective of this open-label, intra-individual study of subjects with rosacea was to evaluate the cutaneous tolerability of a regimen consisting of Cetaphil PRO Redness Control Day Moisturizing Cream (once daily in the morning), Cetaphil PRO Redness Control Night Repair Cream (once daily in the evening) and Cetaphil PRO Redness Control Facial Wash (foam once in the morning and once in the evening). Secondary objectives were to evaluate the effect on transepidermal water loss (TEWL) and cutaneous hydration and to determine the subjects’ evaluation of efficacy, tolerability and future use. A dermatologist examined subjects and measured TEWL and cutaneous hydration on day (D) 0, D7 and D21, when subjects ranked symptoms. Subjects completed a questionnaire on D21.

Results

The per-protocol population consisted of 42 subjects receiving treatment for rosacea. Eleven subjects developed adverse events, none of which were considered to be related to the skincare products. Five subjects showed signs or symptoms that were potentially associated with the skincare products that might suggest poor cutaneous tolerability; these were generally mild. TEWL decreased significantly by a mean of 17% on D7 and a mean of 28% on D21 compared with baseline (both P < 0.001). Skin hydration increased significantly by a mean of 5% on D7 (P = 0.008) and a mean of 10% on D21 (P < 0.001) compared with baseline. Subjects reported that the regimen was pleasant (98%) and effective (95%) and that it offered various benefits; 90% of subjects reported that they would like to continue to use the regimen and would buy the products.

Conclusion

The skincare regimen improved skin hydration and skin barrier function in subjects receiving medical treatment for rosacea and was well tolerated.

Funding

Galderma S.A.

Sex Differences in Keloidogenesis: An Analysis of 1659 Keloid Patients in Japan

Abstract

Introduction

Keloids are a cutaneous fibroproliferative disorder. Despite the fact that keloids are relatively common lesions, the statistics of patient with keloids especially sex difference remain unknown. To better understand it, we conducted an extensive cross-sectional analysis of a large cohort of patients with keloids (n = 1659). The study showed for the first time that female sex may be an inherent keloid risk factor.

Methods

This cross-sectional study of 1659 consecutive patients with keloids who attended a plastic surgery outpatient clinic in Japan in 2014 analyzed age at keloid onset, age at the first medical examination for keloid, and the influence of sex on these variables.

Results

In both male and female patients, the keloids were most likely to start in puberty and there was no significant difference in the mode value for age of onset (16 vs. 20 years). Though female patients were twice as prevalent as male patients at nearly all onset ages, female patients predominated over male patients with a gender ratio of 2.7:1 in cases of onset before the age of 15 years. Moreover male and female patients did not differ in terms of the mean ± SD duration between keloid onset and the first medical examination. This finding shows that female patients do not get their keloids examined earlier than male patients. These observations together suggest that female sex may promote early keloid development due to physiological, not social, reasons.

Conclusion

This is the first report to suggest that female sex may drive keloidogenesis because of physiological reasons. Individuals were most likely to seek a medical examination almost 10 years after onset, regardless of sex. These findings provide new insight into the importance of sex in the development and progression of keloids. Future studies should address the influence of sex hormones on the keloid.

Understanding Treatment Preferences in Patients with Moderate to Severe Plaque Psoriasis in the USA: Results from a Cross-Sectional Patient Survey

Abstract

Introduction

The goal of psoriasis (PsO) treatment is to improve quality of life by lessening the extent and severity of the disease. Traditional systemic drugs and biologic agents are used for the treatment of moderate to severe PsO and recent research emphasizes understanding patient goals and preferences for treatment, to improve overall outcomes.

Methods

An online survey was administered to collect data from 500 adult patients with moderate to severe PsO in the USA. Patients were required to have current or previous systemic therapy use and were excluded if aged 75 or older. Data on demographics, disease burden, treatment use, and patients’ treatment goals and expectations were collected. Descriptive and multivariate analyses examined the factors that predict treatment goals. Subgroup analyses were performed for age, gender, severity, comorbid psoriatic arthritis (PsA), location of PsO, and biologic experience. All analyses were conducted using SAS v9.4 and R v3.4.

Results

Of the 500 adult patients included, 71.6% reported moderate PsO. Patients had a mean (SD) score of 62.4 (23.0) for skin pain, 60.0 (26.3) for fatigue, and 6.6 (2.1) for itch on a scale of 0–100, 0–100, and 0–10 respectively. Mean (SD) score for quality of life (QoL), assessed using Dermatology Life Quality Index (DLQI), was 18.3 (7.3), with more than 90% having moderate/very large/extremely large effect on life. The majority of patients considered “keeping skin clear for 2–3 years” (94%), “overall relief of symptoms” (93.8%), and effective in clearing certain areas” (92.2%) as important attributes of a systemic treatment. Overall, patients expected 50% clear skin in about 2 weeks and completely clear skin in about 4 weeks.

Conclusions

Overall, in this study with more than 70% of patients with moderate disease, patients reported high burden of disease and impact on QoL. This study demonstrates the importance of considering patient perspectives in treatment decisions that are critical for optimizing patient outcomes.

Funding

Eli Lilly and Company.

Erythema of Rosacea Affects Health-Related Quality of Life: Results of a Survey Conducted in Collaboration with the National Rosacea Society

Abstract

Introduction

Persistent facial erythema associated with rosacea may negatively impact quality of life (QoL), self-esteem, and self-confidence. We evaluated burden and health-related QoL (HRQoL) impacts of centrofacial erythema of rosacea.

Methods

A cross-sectional, Web-based survey conducted in collaboration with the National Rosacea Society enrolled adults who self-reported having received a physician diagnosis of rosacea and self-evaluated their current erythema as mild to severe on the validated Subject Self-Assessment for Rosacea Facial Redness. Sociodemographic and clinical characteristics, rosacea symptoms, and their impacts on QoL [validated Impact Assessment for Rosacea Facial Redness (IA-RFR)] and HRQoL [validated Dermatology Life Quality Index (DLQI)] were recorded.

Results

A total of 708 eligible respondents completed the survey (white/Caucasian, 93.5%; female, 83.1%; mean age, 52.4 years). Respondents had mild (59.2%), moderate (33.2%), or severe (7.6%) erythema. The most bothersome symptoms were persistent facial erythema (69.2%) and blushing/flushing (60.9%). Mean IA-RFR scores showed negative impacts across all severities of erythema. The mean (standard deviation) total DLQI score was 5.2 (6.0) overall [mild erythema, 3.8 (4.9); moderate, 5.7 (5.4); severe, 13.4 (8.9); P < 0.0001].

Conclusion

Centrofacial erythema of rosacea represents a substantial HRQoL burden, especially for those with more severe erythema.

Funding

Allergan plc, Dublin, Ireland.

Fractional Erbium-YAG Laser and Platelet-Rich Plasma as Single or Combined Treatment for Atrophic Acne Scars: A Randomized Clinical Trial

Abstract

Introduction

Acne scarring is a common undesirable complication of acne vulgaris. Fractional erbium-yttrium aluminum garnet (YAG) 2940 nm laser and platelet-rich plasma have been used in treating acne scars with variable outcomes. The objective of this study is to assess the efficacy of fractional erbium-YAG 2940 nm laser and platelet-rich plasma as a single line of treatment in comparison with combined treatment in atrophic postacne scars.

Methods

Seventy-five patients were included in this trial and randomized into three equal groups (25 each). Group A was subjected to six sessions of erbium-YAG laser for 6 months, group B was treated with 12 sessions of platelet-rich plasma over the same period, and group C was subjected to six sessions of erbium-YAG laser plus 12 sessions of platelet-rich plasma over the same period. Each subject was evaluated by acne scar grading, photography, and subjective evaluation.

Results

Both treatment modalities showed improvement of acne scars, but the improvement with combined treatment was better than that with erbium-YAG laser or platelet-rich plasma alone regarding scar grade improvement (P = 0.007 and 0.001), clinical improvement (P = 0.001 and 0.001), and patient satisfaction (P = 0.005 and 0.001), respectively.

Conclusions

The combination of platelet-rich plasma plus erbium-YAG laser is superior to either treatment alone for acne scars, with trivial side effects for all treatment modalities.

Trial Registration

ClinicalTrials.gov identifier; NCT03933033.

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